Thursday, May 29, 2008

The National African American Tobacco Prevention Network (NAATPN) has withdrawn its support for the proposed FDA tobacco legislation currently being considered by Congress.Through this decision, which was announced today, NAAPTN becomes the first group to peel off from the broad coalition of anti-smoking and public health groups assembled by the Campaign for Tobacco-Free Kids to support this legislation.

NAATPN provides three major reasons why it is withdrawing its support for the legislation. First, it believes that the menthol exemption, which is apparently the result of a compromise agreed to by the Campaign for Tobacco-Free Kids to appease Philip Morris and protect the financial interests of nation's leading tobacco company, is an unacceptable sell-out of the health of African Americans.

Second, it believes it is inappropriate for the tobacco industry to be involved in crafting legislation designed to regulate the industry.

Third, it believes it was inappropriate for the Campaign for Tobacco-Free Kids to have worked out the compromises in this legislation - especially those which sold out the health of African Americans - without consulting any of the African American health-related organizations which have a primary stake in the issue as well as expertise on menthol and its health impacts.

The following are the key points in the NAAPTN resolution:

"[neither] NAATPN nor any African American health-related organization was included or consulted in the process of developing the proposed legislation."

"a compromise took place that put the African American and other ethnic communities at a disadvantage with regard to the immediate banning of fruit/candy flavorings, but not menthol."

"we are still unclear about what criteria was used to treat menthol differently from the other banned flavorings."

"the need for the regulation of tobacco products is long overdue, but not if the industry selling the products helps to craft the legislation."

"we think the impact of completely removing mentholated products from African American communities will be decreased tobacco advertising, decreased tobacco use, a potential increase in the need for cessation services, improved health and saved lives, and we would rather prepare to address any new challenges than to face continued tobacco use that contributes to disparate health outcomes. NAATPN is very concerned about how many more African Americans would die from mentholated tobacco products while additional studies are deemed necessary and/or are conducted."

"NAATPN has, as part of its mission, to ensure more diverse, inclusive, transparent and beneficial processes in tobacco control."

"Our constituents from across the country have voiced their opposition to the treatment of menthol within H.R. 1108."

"The National African American Tobacco Prevention Network is withdrawing its support for H.R. 1108 in its present form."

The Rest of the Story

Congratulations to the National African American Tobacco Prevention Network for taking a strong and principled stand that the public's health must not be compromised to protect tobacco company financial interests and that federal regulatory legislation should not be crafted by the industry to be regulated.

It was a brave and courageous act for NAATPN to break ranks with the coalition that is supporting the legislation, and I applaud NAATPN for its willingness to reconsider its position in light of new evidence that was presented to the group and for its leadership in changing its decision after considering this new evidence. This is an admirable example of true leadership by a tobacco control organization and it sets a standard of conduct that I hope all organizations will follow.

I sincerely believe that there are numerous other organizations currently supporting the legislation which were also hoodwinked into joining the coalition because they were not provided with the full information regarding the nature of the bill's protective provisions for Big Tobacco and the details of the process by which this legislation was developed: that is, the negotiation of the specific provisions of the bill with Philip Morris and the insertion of numerous loopholes for the sole purpose of protecting Big Tobacco and retaining the tobacco company's support.

I believe that if these groups are informed about the truth behind the bill, many of them will join NAATPN in withdrawing their support for the legislation. If enough groups do so, then it will become necessary to re-work the bill, this time without Philip Morris at the table and with the entire tobacco control and public health community at the table.

You see, the Campaign for Tobacco-Free Kids made two mistakes. First, they agreed to allow Philip Morris to be at the negotiating table with them in crafting the details of the legislation. Second, they did not ask other public health groups to join in the consideration of the provisions of the bill and they did not act with a consensus of the public health community in agreeing to compromises that sell out the public's health to financial concerns of Big Tobacco. Instead, the Campaign appointed itself as the sole arbiter of these critical considerations.

But the biggest mistake the Campaign made, and the one which I feel is most problematic, is its failure to be honest and forthright and to tell the truth about the development of this legislation and the process by which the specific provisions in the bill were agreed upon. As I have shown repeatedly on this blog, the Campaign continues - to this day - to deceive its constituents, other health groups, and the public about the process that led to the legislation.

The Campaign is running, in fact, an entire campaign of deception designed to hide the fact that Tobacco-Free Kids appointed itself as the sole representative of public health, negotiated the bill with Philip Morris, and agreed to numerous truck-sized loopholes in the bill to protect the financial concerns of Big Tobacco.

In truth, then, the bill contains numerous special protections for the nation's tobacco companies. Thus, it institutionalizes special protections for Big Tobacco, it doesn't end special protections for Big Tobacco as the Campaign has publicly claimed.

There is no place in tobacco control for negotiating legislation with Big Tobacco and letting the tobacco companies have a hand in the writing (crafting) of the legislation that will regulate them.

There is no place in tobacco control for asking a tobacco company to make the key decisions regarding what provisions in federal legislation are acceptable and which are not, and to make compromises solely to appease the concerns of that tobacco company, purely on financial grounds.

There is no place in tobacco control for selling out the public's health, especially that of a particularly disadvantaged population, in order to achieve political compromises to try to advance legislation and especially without the consent of that group's representatives.

There is no place in tobacco control for the exclusion of every other group in our community in making decisions about what aspects of the public's health to sell out in order to appease Philip Morris.

And even if all of the above things do happen, there is no room in tobacco control for being dishonest about these facts and for deceiving the entire tobacco control community.

At this point, the Campaign for Tobacco-Free Kids cannot take back its having negotiated legislation with Philip Morris or having appointed itself as the sole public health representative at the table. However, it can reverse its course in terms of the campaign of deception. It can come clean and tell the truth about the process that led to the legislation. It can explain to us how the bill resulted from a Congressionally-mediated negotiation between itself and Philip Morris. It can explain the fact that a deal emerged from those negotiating sessions and that no input from the public health community at large was possible after that deal had been forged.

A lot more than the FDA legislation is at stake. The diversity, inclusiveness, transparency, honesty, and integrity of the tobacco control movement is at stake. And it all depends on how the Campaign for Tobacco-Free Kids will respond to this crisis.

Wednesday, May 28, 2008

Volusia County (Florida) has announced a new policy: smokers will no longer be eligible for employment in the County Sheriff's Office or in the county's beach patrol or corrections division.

According to an article in the Orlando Sentinel: "All new deputies at the Volusia County Sheriff's Office must be nonsmokers who can pass a physical-abilities test, according to a contract approved at Thursday's County Council meeting. New employees of the county's Beach Patrol and division of corrections, who are not part of a union, will be held to the same standard, County Manager Jim Dinneen said. 'If we don't do this as a government, I think it would be irresponsible,' Dinneen said, adding that he would like to implement programs to discourage other county employees from smoking and eventually ban employees from smoking on county premises."

The Rest of the Story

If it would be irresponsible of the county not to bar smokers from employment in the Sheriff's Office, then is it not also irresponsible of the county to allow fat people to work in that office? And is it not also irresponsible to allow people who cannot demonstrate that they are on a vigorous physical activity regimen to work for the Sheriff's Office? And it must also be irresponsible to allow people who do not eat a nutritious diet to work for the Sheriff's Office? And why stop with that office? Isn't it irresponsible to allow smokers, fat people, and individuals who do not vigorously exercise and eat a nutritious diet to work for any department in the county?

The physical activity test makes sense since this is a bona fide job requirement to be a police officer. But if you are going to require a physical activity test, then shouldn't that be the determining factor? Why does it also matter if you smoke, once you've shown that you can pass the physical activity test? Or more importantly, why does it matter if you smoke, but not if you are obese, eat a terrible diet, or get little to no exercise?

The County manager implied that this program is intended to "discourage" county employees from smoking. However, this is not an incentive program at all. It is a prohibition of smoking among new employees. Thus, it does not discourage smoking; it prohibits it. An appropriate worksite health promotion program would try to help employees who want to quit smoking, not force them to quit or require them not to smoke in order to be employed in the first place.

An employee wellness program should be run by the employer for the employees who happen to have been hired. The wellness program should not be run by the personnel office, implemented by weeding out people with certain "undesirable" health habits.

And what is very troubling is that what is being considered "undesirable" is very subjective. Smoking is being singled out, but other poor health habits are being ignored. If you want to be consistent, then just require all new hires to be health nuts, who don't smoke, don't drink, exercise vigorously every day, eat yogurt and granola, and avoid tater tots like the plague.

According to his own sworn testimony, the chair of the expert panel which recently released national recommendations for the use of smoking cessation medications by physicians receives up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

Despite this huge financial conflict of interest with Big Pharma, the panel chair - Dr. Michael Fiore - failed to recuse himself from the panel and the panel organizers failed to remove him from the panel.

According to his testimony in the Department of Justice tobacco lawsuit: "GlaxoSmithKline gave a grant to the University of Wisconsin that established a chair for the treatment of tobacco dependence. That donation by GlaxoSmithKline was to the University. Named chairs at the University of Wisconsin provide the person who sits in that chair to access to the revenue generated from the investment on the initial grant. So in this instance, I have access to up to $50,000 per year to support my University approved and sanctioned educational, research, and policy activities."

Dr. Fiore also apparently failed to disclose all of his financial conflicts of interest in his initial financial disclosure required for his participation on the panel. The disclosure form asks for "complete" disclosure of all conflicts over the past 5 years. On the form, Dr. Fiore denied any current honoraria or consulting arrangements with pharmaceutical companies, but apparently failed to disclose the fact (based on his own testimony) that: "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

The financial disclosure form for the Clinical Practice Guideline was signed in 2006, meaning that Dr. Fiore should have disclosed any and all consulting work with pharmaceutical companies dating back to 2001. Dr. Fiore's testimony in the DOJ lawsuit was in 2005, meaning that he admitted doing pharmaceutical consulting work during the period 2001-2005 ranging between $10,000 and $40,000 per year. I do not find this consulting work disclosed on the primary financial disclosure form signed by Dr. Fiore on September 5, 2006.

The Rest of the Story

There are two important aspects to this story:

1. The Failure of AHRQ to disqualify Dr. Fiore from the Panel or for Dr. Fiore to Recuse Himself

Given the magnitude of the financial conflict of interest with a pharmaceutical company, and the fact that this company is the manufacturer of a number of smoking cessation drugs whose use, on a national basis, was to be considered by the panel, I find it inexcusable that Dr. Fiore failed to recuse himself from the panel and that the Agency for Healthcare Research and Quality (AHRQ) which convened the panel failed to remove him from the panel, or at very least, from its chairmanship.

The type of conflict of interest reported by Dr. Fiore is the largest possible conflict of which I am aware: an endowed professorship. This is the highest possible level of corporate support for a professor of which I am aware, and it undoubtedly makes the professor indebted to the company. The company is essentially providing direct support for the professor's career and for his academic endeavors. This creates a far greater conflict than merely providing a research grant, consultant fees, honoraria, or fees for speaking engagements or product reviews.

I would be overjoyed to obtain an endowed professorship and if a company gave me $50,000 a year to spend on my research and other academic endeavors, I most certainly would be deeply indebted to that company. It represents the highest level of financial security for a professor.

So I can't conclude anything other than that it is inexcusable both for Dr. Fiore to participate on the panel and for the Agency not to disqualify Dr. Fiore from participating.

It's not like the potential conflict is a small one. It was well known that the panel would be reviewing data and making recommendations for the national use of smoking cessation drugs manufactured by the company in question. This is a greater conflict than in most research situations, where a particular finding could have some small incremental effect on the use of a drug. Here, the express purpose of the panel was to develop recommendations that would serve as a guideline for how physicians throughout the country should or should not prescribe these medications. A decision by the panel to either recommend pharmaceuticals for all patients or to recommend a cold turkey approach would have profound financial implications for the pharmaceutical companies, and for GlaxoSmithKline in particular.

2. The Failure of the Panel Chair to Disclose Recent Conflicts of Interest on the Primary Disclosure FormI do not understand why it appears that Dr. Fiore failed to disclose his consultant work for pharmaceutical companies on the primary disclosure form. In his testimony, he acknowledges receiving between $10,000 and $40,000 annually from pharmaceutical companies for consulting work during the period 2001-2005. However, I would interpret his primary financial disclosure form to indicate that he has not done any consultant work for the pharmaceutical companies for the past 5 years (that is, from 2002-2006). This appears to be inconsistent with the testimony, and therefore it appears to be inaccurate.

The disclosure form states: "In keeping with recent JAMA recommendations, Dr. Fiore does not accept honorarium nor do consulting work for the pharmaceutical industry."

Since the form requires disclosure of all financial interests during the past 5 years, the interpretation of this disclosure statement is that Dr. Fiore does not currently do consulting work for the pharmaceutical industry, and has not done such consulting work for the past 5 years.

Based on Dr. Fiore's testimony, this appears not to be true. Thus, this appears to be a dishonest, or at very least, a severely flawed and incomplete disclosure.

The fact that Dr. Fiore later disclosed 2005 consultant payments from one pharmaceutical company does not compensate for the failure to disclose similar conflicts during the years 2002-2006, which were specifically asked about in the primary disclosure form.

There is additional evidence that Dr. Fiore failed to disclose consultant payments from pharmaceutical companies for the five-year period prior to September 5, 2006, when he signed the primary disclosure form.

First, in a 2002 article in Chest, it discloses that: "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

Second, in a 2008 JAMAarticle, it discloses that: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

Thus, in the five-year period asked about in the primary disclosure form for the panel, it appears that Dr. Fiore should, at very least, have reported his lectures and consultation for Pfizer. In addition, it appears that he also should have reported his serving as an investigator on research grants funded by four pharmaceutical companies.

In addition, a Wall Street Journalarticle of February 8, 2007 reports that: "Between 1999 and 2004, Dr. Fiore personally pocketed $10,000 to $40,000 a year from the quitting-aid industry for honorariums and consulting work. He says he stopped such work in 2005." This article corroborates the information from other sources that Dr. Fiore had pharmaceutical-related consultancy income for the years 2002-2004 that should have been reported on the Clinical Practice Guideline disclosure form.

Perhaps the most striking aspect of this story is not the failed disclosure nor the failure to recuse himself from the panel, but instead is Dr. Fiore's apparent unawareness of (or unwillingness to admit) the fact that there is a conflict of interest. Apparently, Dr. Fiore denied to Helliker (author of the Wall Street Journal article) that there is a conflict of interest. Helliker wrote: "Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies."

As evidence mounts that the smoking cessation drug Chantix is associated with severe and fatal side effects, the unacceptable consequences of a conflicted expert panel making national recommendations become apparent. If these reports are true and the accidents and deaths being reported are true side effects of Chantix, then the panel's recommendations may not only be an example of highly biased science, but they might also result in the loss of lives.

Just Friday, the Los Angeles Times reported on a link between Chantix use and traffic accidents, a link which the FDA is currently investigating. And on Thursday, the Federal Motor Carrier Safety Administration banned the use of Chantix by anyone seeking a commercial motor vehicle license.

While there is room for debate about issues such as whether Chantix should still be prescribed for smoking cessation and about whether a pharmaceutical-based or a cold turkey-based approach would be more effective for smoking cessation on a population level, what I don't think there is room for debate about is whether decisions about these issues should be made for the nation by experts who have severe financial conflicts of interests with Big Pharma.

Finally, I think it is important to point out that while pharmaceutical funding of research is a necessity, having conflicted members of an expert panel is not. While the former is acceptable so long as the conflict is disclosed and the company has no control over the research, the latter is simply not acceptable.

Friday, May 23, 2008

The Federal Aviation Administration (FAA) announced yesterday that it was banning the use of the smoking cessation drug Chantix by pilots and air traffic controllers because of hundreds of reports of serious side effects of the medication - effects which could endanger the lives of flight crews and passengers.

According to a CBS Newsarticle: "Pfizer Inc.'s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group's report about serious physical side effects prompted the Federal Aviation Administration to ban the drug's use by pilots and air traffic controllers. The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements. 'We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,' the researchers said in the report. ... The Institute for Safe Medication Practices' report and Wednesday's move by the FAA come months after the FDA said the connection between Chantix and serious psychiatric problems is 'increasingly likely.' Pfizer had already added stronger warnings to the drug's label before that opinion was released in February."

A Los Angeles Timesarticle added: "'These data provide a strong signal that the risks of [Chantix] treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers,' the report said. Prescription drugs are usually tested on a few thousand people before approval, but serious problems may not emerge until many more patients have used the medication for a sustained period. Responding to the study, FDA spokeswoman Susan Cruzan said: 'We agree that these findings are a signal that requires further investigation and confirmation, and the FDA has been conducting a review of the adverse events associated with Chantix.'"

Of note, the expert panel which recently released a clinical practice guideline for physicians treating patients who smoke recommended the use of smoking cessation drugs for every smoking patient and specifically promoted the use of Chantix.

Interestingly, nine members of the panel had financial conflicts of interest because of their having received funding from pharmaceutical companies, most of which are the manufacturers of various smoking cessation drugs.

The chair of the panel had a conflict of interest specifically with Pfizer, manufacturer of Chantix. It also appears that several members of the panel had received money for consultation on a new smoking cessation drug, which very well might have been Chantix.

The Rest of the Story

This is why financial conflicts of interest simply should not be tolerated in expert panels like the one on smoking cessation, especially when they are formulating national practice guidelines.

It is inexcusable to me that a individuals with financial conflicts of interest with Big Pharma would be allowed to serve on a panel like this, much less to serve as the chair of the panel.

In light of the report warning against the use of Chantix, the ban on Chantix by the FAA, the agreement of the FDA with the main contention of the report, and the ongoing investigation by the FDA of the potential for severe side effects of the drug, it is inappropriate for the scientific panel to have promoted its use by physicians throughout the country.

But what makes that recommendation truly problematic is that it has the appearance of being a biased recommendation because of the existence of these conflicts of interest.

It is one thing for a conflict of interest to result in bias which simply results in a flawed scientific finding. It is quite another for a conflict of interest to result in a recommendation which might very well actually kill people.

While I think there is room for debate about the costs versus benefits of recommending the use of Chantix give the existing data, I do not think there is room for debate about the appropriateness of allowing a conflicted panel with a conflicted chair to conduct such an analysis and to ask the nation to rely on that panel to formulate guidelines for clinical practice.

Thursday, May 22, 2008

After carefully reviewing the evidence from a number of sources, including published articles and sources close to the process, I think it is clear that the FDA legislation currently before Congress is the result of negotiations that took place between the Campaign for Tobacco-Free Kids and Philip Morris, mediated by several members of Congress.

While it may or may not be the case that Tobacco-Free Kids and Philip Morris representatives were in the same room at the same time (at least one newspaper reports that such did occur), it hardly matters. The point is that the process that led to the development of the FDA legislation was essentially a mediated negotiation between these two parties.

This means that the compromises in the bill are present for the purpose of appeasing Philip Morris and retaining its support for the legislation. In other words, the loopholes in the bill are present in order to protect the financial interests of the tobacco industry. Thus, the Campaign for Tobacco-Free Kids has sold out the health of the American public in return for Philip Morris' support of the legislation.

This information, which may come as a revelation to many in the tobacco control field (because the Campaign for Tobacco-Free Kids has not been forthright about its negotiations with Philip Morris and has gone to great lengths to hide the process that led to the specific provisions in the legislation), is important because it demonstrates that the FDA legislation is a dream-come-true for Philip Morris: it is an opportunity to essentially let Philip Morris write the legislation by which its products will be regulated. No corporation could ask for any more.

It is entirely inappropriate to allow the regulated industry to be involved in the crafting of the legislation to regulate that industry. Public health laws should not be the result of a negotiation where we ask the regulated party to indicate what public protections it can and cannot support or live with.

I believe the public revelation of these facts may lead to the crumbling of this legislation. Why? Because I don't think this is something that the public can tolerate. In an era in which the FDA and other federal agencies are under intense criticism for the politicization of the regulatory process and the undue involvement of corporate lobbyists in the crafting of legislation and regulations, I don't think the public is going to tolerate the fact that the legislation which is supposed to end special protections for Big Tobacco (in the words of the Campaign for Tobacco-Free Kids) was actually developed through a negotiation with the biggest element of Big Tobacco: Philip Morris.

I have spoken to a number of people who work for groups which are supporting the FDA tobacco legislation who have told me that they were not aware that Philip Morris was involved in the development of this legislation and that if this news becomes public, it will be difficult for them to continue to support the legislation. What previously was a political asset will then be viewed as a liability.

The rest of the story is that the legislation which is billed as ending special protections for Big Tobacco is actually the result of a negotiation with Big Tobacco. Philip Morris participated in the crafting of the legislation, and in particular, the negotiation about the inclusion or exclusion of various specific provisions in the bill. These provisions sell out the public's health for the benefit of tobacco financial interests.

This is policy making at its worst: allowing the regulated industry to play a major role in the crafting of the legislation and its key provisions.

While I have not been able to convince many public health groups to oppose the legislation on its merits (or lack of merits, I should say) because there is disagreement in strategic judgment about the likely effects of the legislation on the public's health, there is very little disagreement in the tobacco control and public health communities that we should not formulate tobacco control policy by negotiating with Philip Morris to see what the nation's largest cigarette company finds acceptable or unacceptable.

To the best of my knowledge, there is only one tobacco control group out there which thinks it is acceptable to negotiate with Philip Morris to determine what policy provisions they can live with and what provisions are deal-breakers: and that's the Campaign for Tobacco-Free Kids. To the best of my knowledge, even the other organizations which are a central part of the coalition supporting the legislation were reluctant, if not completely unwilling, to sit down with Philip Morris at the negotiating table.

Now that the process that led to the legislation has come to public light, it is going to become increasingly difficult for those groups to defend their support of the process. Now that the process itself has been shown to be tainted, that taint extends not only to the Campaign for Tobacco-Free Kids - which is the only group which actually negotiated with Philip Morris - but also to the other groups supporting the deal. It becomes difficult for these groups to separate themselves from the stench of the process that led to the legislation. Supporting the bill means, to some extent, supporting or at least condoning the process that led to the legislation. And for most groups, that is simply not going to be possible any longer.

Regardless of any uncertainty about how anti-smoking groups will feel about this tainted process, it is clear to me how the public will feel. The public is going to think that the process stinks, as well they should. This is exactly the kind of special interest involvement in policy making that has become a major campaign issue during the present election cycle.

Public health groups should simply not be formulating tobacco control policy by sitting down with Philip Morris to figure out what public health protections the company is willing to live with. Policy should be formulated, instead, by sitting down with the rest of the public health community and developing the best possible legislation based on the evidence regarding best practices.

If compromise needs to take place, it should take place in an open forum, where all citizens can participate - at least through their elected representatives. It should not take place in a closed room negotiation that the public (and the rest of the public health community) is not aware of.

Here are excerpts from and links to some of the articles which document, provide evidence for, or conclude that the FDA tobacco legislation before Congress represents the result of a process of negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, mediated by members of Congress:

"Moments after lawmakers unveiled landmark legislation last spring to impose the most sweeping regulations on cigarettes in history, two of the people most closely involved in the momentous compromise bumped into each other leaving a press conference on the deal. Though they were just a few steps from each other outside the Senate's television studio, Matt Myers and Mark Berlind didn't shake hands, embrace or even say hello. Instead, they moved silently past each other, carefully avoiding eye contact. Myers and Berlind may be the biggest winners if Congress approves the tobacco bill this week. But they're about as comfortable as boys and girls at a sixth-grade dance. It's easy to see why: Myers is the president of Campaign for Tobacco Free Kids, a group dedicated to outlawing smoking. Berlind is the chief legislative counsel for Altria Group, the parent of Philip Morris USA, the nation's leading cigarette maker. But the awkward encounter that day belies an uncomfortable alliance between the two men and their organizations that has helped to move the tobacco bill closer than ever before to the president's desk. In the next few days, Members of Congress will decide whether they will include the compromise tobacco bill in a corporate tax bill that they hope to approve by Friday. Thanks to separate but equally calculated decisions by Philip Morris and the Campaign for Tobacco Free Kids, each has broken ranks with their typical allies, formed a secret alliance and met clandestinely to iron out key sticking points on the legislation.

The talks between Philip Morris and the Campaign for Tobacco Free Kids took place on Capitol Hill even as the two sides battled over a $200 billion Justice Department lawsuit in a federal courthouse a few blocks down Pennsylvania Avenue. The face-to-face negotiating sessions and conference calls were so sensitive that Philip Morris and the Campaign for Tobacco Free Kids refused to tell even their closest allies. Added Scruggs, a one-time aide to former Senate Majority Leader Trent Lott (R-Miss.): "It's far from an alliance. We have a commonality of interests in seeing the same piece of legislation enacted. They are working very hard in support of the same legislation that we happen to be working in support of." Despite the comments, Philip Morris and the Campaign for Tobacco Free Kids are well under the sheets on the tobacco bill. But getting them to take off their slippers took years. The seeds of today's coalition were planted years ago, when executives at Philip Morris and Tobacco Free Kids quietly made separate decisions about how they would deal with tobacco legislation in the future. ...

Philip Morris executives soon cautiously reached out to the company's longtime adversaries in the antismoking community, including Scott Ballin, a pragmatic antismoking advocate and former chief of the American Heart Association. Ballin had been searching for creative ways to move a tobacco bill through Congress. In a November 2001, Steven Parrish, the company's senior vice president for corporate affairs, sent a startling letter to Ballin in which he said Philip Morris wanted to talk to officials in the antismoking community about drafting a bill. Still, settling on specific language would prove to be difficult for Philip Morris and the antismoking advocates. The 2001-02 session of Congress ended without legislation. Last year also failed to bear fruit after Sen. Judd Gregg (R-N.H.) failed to forge a deal. But behind the scenes, a new player emerged who was able to bring the two sides together: Sen. Mike DeWine (R-Ohio). When Gregg called off talks in the fall of 2003, DeWine quietly reconvened negotiations. Led by aide Abby Kral, DeWine's staff pressed Philip Morris, the Campaign for Tobacco Free Kids, national health organizations and other stakeholders to come together on a bill. Complicating the process for DeWine was the fact that few antismoking officials would agree to negotiate with Philip Morris. "There is just no benefit to working with them," said Paul Billings, the vice president of national policy at the American Lung Association. "They still are an evil company. They nearly sell more cigarettes than all other cigarette makers combined." Unbeknownst to their allies in the public health community, representatives of the Tobacco Free Kids spoke with Philip Morris lobbyists several times and met at least once to iron out language that both sides could accept. Both sides say most of the talks were arranged by DeWine's office because officials from Tobacco Free Kids and Philip Morris felt uncomfortable dealing with each other. Several times, however, Myers spoke directly to Philip Morris officials either face-to-face or by phone. "I believe there was at least one meeting with multiple parties present where both sides were there," said Myers. Even the talks over the telephone could be awkward at times. Because neither side wanted to initiate phone calls to the other, Philip Morris and Campaign for Tobacco Free Kids officials relied on intermediaries to set up conference calls so they could talk directly. Despite the difficulties, both sides say the direct talks were helpful."

"But how has Philip Morris attempted to implement these multiple policy goals? One key element of this campaign has been "constructive engagement" with key health groups and advocates. The beginning of this highly unusual effort by Philip Morris began in November 2001 when secret negotiations, of which many health advocates were unaware, were initiated between Philip Morris and the Campaign for Tobacco-Free Kids. In 2003, after a temporary impasse, these secret negotiations were reconvened by US Senator Mike Dewine (Republican, Ohio). A compromise was eventually struck that led in 2004 to the introduction in the US Senate of an FDA tobacco regulation bill by Senators Edward Kennedy (Democrat, Massachusetts) and Mike Dewine (Republican, Ohio)."

"Unfortunately however, the process that has been followed in Congress thus far has stymied dialogue and engagement. In the case of this legislation, a backroom agreement between Philip Morris and the Campaign for Tobacco Free Kids seems to have been concluded even before the legislation was officially introduced — making moot any comprehensive substantive hearings and suggested changes. The agreement, while understandable in some ways, is far from being transparent and reflective of open and deliberative government. It fails to provide opportunities for discussion about how the legislation can be improved."

5. PR Watch Article:"After all, PM [Philip Morris] has a corporate mandate to increase profits for its shareholders, so PM would not support this legislation if it wasn’t going to benefit its bottom line, and it is practically an axiom in public health that whatever benefits PM’s bottom line is going to be bad for public health. That’s what makes this bill especially troubling to people who study tobacco industry documents; it is clear that PM had a hand in crafting it. That alone sounds like a lot, but PM's efforts to enact it are clearly delivering the company a hefty side-benefit of causing dissent within the tobacco control community over its passage. Neither the content of the bill nor the strident disagreement about it among tobacco control professionals is happenstance. ...

PM approached the National Campaign for Tobacco-Free Kids (CTFK) seeking input to formulate its preferred FDA regulations. As the Plan mentioned, PM found common ground with CTFK on the youth smoking issue, and engaged CTFK in its Regulatory Strategy Project to craft FDA regulations in its favor. Now CTFK is helping PM stump for passage of a bill that many highly experienced tobacco control people and organizations consider deeply flawed in many respects. An article in the October 5, 2004 edition of Roll Call, the newspaper of Capitol Hill, titled "How Philip Morris, Tobacco Foes Tied the Knot," describes the uncomfortable first meeting between Matt Myers, President and Chief Executive Officer of the Campaign for Tobacco Free Kids, and Mark Berlind, Associate General Counsel of Philip Morris, and the subsequent secret negotiations the two parties carried on without notifying others in the tobacco control community. ...

That the current FDA bill was created through secret negotiations apparently orchestrated by PM certainly seems to be the case. No other public health entities with exceptional experience in tobacco control were asked to participate in formulating the proposed regulations -- no current or former Surgeons General, no one from the American Association of Public Health Physicians, none of the many prominent longtime public health advocates around the country with decades of experience fighting the tobacco industry, and no public health advocacy groups that have detailed knowledge of tobacco industry strategies or the best track records of success in reducing public smoking, like Americans for Nonsmokers Rights or the state Groups to Alleviate Smoking Pollution (GASPs). No scholars in tobacco industry documents or tobacco policy were invited. The amount of valuable tobacco control expertise and knowledge that was summarily excluded from the negotiations to create the bill is amazing--and highly suspect.

CTFK ducked questions about the "secret negotiations" claims and instead steered us to "FDA" section of their Website and suggested we contact the Senate sponors of the bill for comment. The American Cancer Society, which has been fighting tobacco for decades, declined to comment when asked how they felt about being excluded from the negotiations."

In this press release, entitled "Tobacco Bill Negotiations Failed Due To Loopholes Sought By Tobacco Industry," the Campaign for Tobacco-Free Kids itself admits that there were indeed ongoing negotiations with Philip Morris to try to achieve a deal on FDA tobacco legislation: "In a statement released late Wednesday, Philip Morris claimed that negotiationsover proposed legislation to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products “have broken down due to the last-minute insistence that the FDA be given the power to ban the sale of all cigarettes to adults.” This statement is completely false, and Philip Morris knows it. The negotiations were not about whether the FDA should be permitted to ban cigarettes or other tobacco products. ...

The fact that this offer was dismissed out of hand is a clear indication that Philip Morris and some in Congress wanted to tie the FDA’s hands in requiring any changes in tobacco products, not just to prevent FDA from banning cigarettes. Rather than accept the compromise language we offered, some in Congress insisted on the inclusion of ambiguous language in the section entitled Powers Reserved to Congress that would have allowed the tobacco industry to challenge FDA efforts to require the removal of known harmful substances from current tobacco products. ... "The negotiations broke down..."

Wednesday, May 21, 2008

An article by economist Michael L. Marlow, Professor of Economics at California Polytechnic State University, appearing in the May issue of Econ Journal Watch (home page here), highlights the ongoing debate over the acute cardiovascular effects of secondhand smoke which I have helped bring to light.

Professor Marlow discusses the paper I published in Epidemiologic Perpsectives and Innovations, in which I analyzed the scientific evidence related to the acute cardiovascular effects of secondhand smoke and concluded that numerous anti-smoking organizations are distorting and misrepresenting the scientific evidence in a way that grossly exaggerates the true acute health effects of brief tobacco smoke exposure.

Dr. Marlow writes: "Siegel’s (2007) paper discusses what he refers to as wild claims regarding adverse health effects of second-hand smoke of many pro-ban advocates and discusses how he has been personally attacked for criticizing such claims. ... The claims that Siegel is referring to are contained in his blog tobaccoanalysis.blogspot.com and interested readers might be rather surprised at the degree to which Siegel describes the “junking” of epidemiology. In brief, Siegel (2007) has been vehemently attacked for criticizing views of leading anti-tobacco activists on the extent of health risks to non-smokers. Siegel fears: 'The dissemination of inaccurate information by anti-smoking groups to the public in support of smoking bans is unfortunate because it may harm the tobacco control movement by undermining its credibility, reputation, and effectiveness.'"

"A rather public fight is ongoing between Siegel and Stanton Glantz, with the latter one of the leaders of the tobacco control movement and co-author of papers quoted here several times. As quoted in a recent Boston Globe article, Glantz states the following about Siegel: 'I view him as a tragic figure—he has completely lost it. His view is that everybody in the tobacco control movement is corrupt and misguided except for him. You have to be careful what you say to preserve credibility in academic circles, and he is not doing that.' (Glantz qtd. in Beam 2007)."

Dr. Marlow also discusses the efforts to discredit Dr. James Enstrom of UCLA after he published findings which questioned the relationship of secondhand smoke exposure and lung cancer. As I highlighted here, Dr. Enstrom was falsely accused by the American Cancer Society of scientific misconduct.

The Rest of the Story

This is a very interesting article and I find it fascinating to observe how someone who really started out with only a passing interest in the tobacco science and policy debate slowly came to the appreciation that some inappropriate tactics are being used by the anti-tobacco movement. Most imporantly, the article discusses the false accusations that have been made against a number of researchers and the threats of career harm that may inhibit tobacco researchers from expressing opinions that run counter to those of the established dogma in tobacco control.

On a personal note, I do have to object to Dr. Glantz' comment about me. I have not "completely" lost it. I have only "partially" lost it. I think he is guilty here of quite an exaggeration.

Also, I do not ever remember stating that I am not corrupt and misguided, so that statement is wrong as well.

I do agree with one thing Dr. Glantz said: that you have to be careful what you say in the tobacco control academic circle. It is true that if you are not careful and you express an opinion that runs counter to the dogma in tobacco control, you run the risk of being ostracized and cast out from the movement. As I have learned, it's not your integrity or the quality of your science that is most important; it's the direction of the results that you publish. In other words, how favorable your results are in the eyes of the most extreme in the tobacco control movement.

When I published articles concluding that secondhand smoke is a health hazard for bar and restaurant workers, I was viewed as a reputable expert in the tobacco control movement. But as soon as I expressed my opinion, based on an equally rigorous analysis of scientific evidence, that anti-smoking groups were exaggerating the science by stating that 30 minutes of secondhand smoke can cause atherosclerosis, I was no longer a reputable expert. Instead, I instantly became a tobacco stooge, a traitor, a tragic figure, and a tobacco defender (these are their words, not mine).

Interestingly, this change occurred overnight. One day a heroic scientific expert in tobacco control. The next day a tragic figure losing his marbles completely. What a tragic story.

Tuesday, May 20, 2008

According to an article in the Sarasota Herald-Tribune, Sarasota County announced today that it will no longer hire smokers. In fact, the County will not hire anyone who has smoked within the past year. And the County will require that new hires prove their non-smoking status by submitting to a cotinine test.

According to the article: "To be considered for a county job, applicants will have to indicate that they have not used any tobacco products in the preceding year, according to a county press release. Prospective employees will also be screened for tobacco use during the physical examination for new hires, and any applicant with nicotine above a 'specified amount' in his or her system will be disqualified for employment, the press release says. The new policy will encourage county workers to have more healthy lifestyles and to keep the county from incurring higher insurance costs because of tobacco-related claims, the release says."

The Rest of the Story

While policies that deny employment to smokers are generally legal, the requirement Sarasota is imposing on new hires - that they submit to an invasive medical test to determine their cotinine level - represents an unwarranted invasion of privacy that just may prove to violate state right-to-privacy laws.

As I reported, A U.S. District Court judge for the District of Massachusetts ruled earlier this yearthat there are sufficient legal grounds for a lawsuit filed by a smoker against The Scotts Company to proceed based on the contention that the company violated the Massachusetts right-to-privacy statute. The plaintiff - Scott Rodrigues of Bourne, Massachusetts - was fired by Scotts after failing a urine cotinine test.The District Court ruled that there are sufficient grounds to proceed with the case to determine whether Rodrigues' firing violated Massachusetts privacy law.

At least in Massachusetts, an invasion of privacy complaint may well have legal merit. As Judge O'Toole pointed out: "Section 1B of Chapter 214 of the Massachusetts General Laws provides: “A person shall have a right against unreasonable, substantial or serious interference with his privacy.” The right is broadly stated and it has been left to the courts to determine its scope. It has been held that the statute “proscribe[s] the required disclosure of facts about an individual that are of a highly personal or intimate nature when there exists no legitimate, countervailing interest.”

The lawyers for Scotts will argue that the company's interest in saving health care costs by not hiring smokers outweighs the interference with privacy entailed by requiring a prospective employee to submit to a urine cotinine test. However, my personal feeling is that there is simply no relationship between an employee's smoking status and his or her bona fide qualifications for employment with the Scotts Company. Thus, in my mind, the countervailing interest in this case is not legitimate, or at least, it does not outweigh the invasion of privacy regarding the lawful conduct of the employee in the privacy of his or her own home.

A ruling in Scotts' favor would open the door to all kinds of intrusive medical testing of prospective employees that has no relationship to bona fide job qualifications. If saving health care costs is found to be a large enough countervailing interest to justify intrusive medical procedures that require testing of bodily fluids, then all kinds of other intrusive medical testing are justified, not only cotinine testing.

For example, how about requiring diabetics to submit to a hemoglobin A1C blood test to make sure that their blood sugar is under control? How about requiring people at high risk of sexually transmitted diseases to provide specimens for testing to make sure they are not infected with various microbial agents? How about requiring female employees to submit to an HPV test to make sure they are not at risk for cervical cancer?

I hope that a potential Sarasota County employee who is denied employment based on a cotinine test brings an action under privacy law so that this potential legal claim can be tested.

Regardless of its legality, this policy is overtly discriminatory and inappropriate.

Sunday, May 18, 2008

A source who was involved in the process that led to the FDA tobacco legislation currently before Congress has confirmed that the menthol exemption in the legislation was considered to be a deal-breaker by Philip Morris and that the Campaign for Tobacco-Free Kids caved in to this Philip Morris demand in order to appease the nation's largest tobacco company. The source also confirmed that the legislation represents the results of a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, which was mediated by Congressional leaders.

The Rest of the Story

It is now clear that the FDA legislation represents an attempt by Philip Morris to determine federal tobacco regulatory policy, and that the Campaign for Tobacco-Free Kids is a willing accomplice in the tobacco company's efforts.

It is also clear that the Campaign for Tobacco-Free Kids has sold out the public's health in order to help protect the financial interests of the nation's largest cigarette company. The menthol exemption is just one example of a sell-out that the Campaign made to protect Philip Morris' financial interests. In fact, there are numerous, huge loopholes in the legislation that are present solely to protect Big Tobacco, and the Campaign sold out the public's health in each of these areas.

I think it is completely inappropriate for Philip Morris to be involved in the development of federal legislation regarding tobacco products. You don't develop legislation by sitting down with the manufacturers of the product and asking them to indicate what they demand to be present or absent in the legislation, and then use that as a baseline for your bill.

But what is even more inappropriate is for a public health group to agree to develop federal legislation by sitting down with Philip Morris to negotiate a bill.

And the final clincher, which makes the Campaign for Tobacco-Free Kids' behavior inexcusable, is for that public health group to take it upon itself to make all the decisions regarding what tobacco company demands to accede to, without the knowledge of, and input from the rest of the public health community.

By the act of sitting down and negotiating a critical piece of federal tobacco legislation with Philip Morris and excluding all other public health groups, the Campaign for Tobacco-Free Kids co-opted the entire tobacco control movement. It took the entire movement into its own hands and acted as the self-proclaimed representative for all of us, without our consent.

By doing so, the Campaign for Tobacco-Free Kids violated two of the basic principles of public health practice:

1. Inclusion: It is inexcusable that the Campaign failed to include the majority of tobacco control advocates in the process. The exclusion of advocates from communities of color is particularly inexcusable. The Campaign should never have negotiated with Philip Morris without the knowledge and consent of the tobacco control community, and it should certainly not have made decisions to sell out to Philip Morris' demands without the knowledge and consent of our community.

2. Transparency: It is also inexcusable that the Campaign conducted its negotiations with Philip Morris in private and that it has hidden and continues to hide the entire process of these negotiations in a shroud of secrecy.

I can say with certainty that if I were in charge of a national tobacco control organization, I would never take it upon myself to make all the decisions for the tobacco control movement regarding what compromises should be made in federal legislation. I would never have allowed Philip Morris to have a hand in making decisions regarding the limits on regulation of their products in the first place.

But even had I decided to cave in to Philip Morris on some of their key demands, I would never have made those decisions myself as a self-proclaimed representative for all of tobacco control.

When I think about it, the Campaign for Tobacco-Free Kids has an incredible amount of self-importance and arrogance to even think about putting themselves in a position to negotiate federal tobacco policy for the rest of the tobacco control community without our knowledge, input, or consent.

Who appointed the Campaign for Tobacco-Free Kids to be the tobacco control czar for the United States?

Through these actions, I believe that the Campaign for Tobacco-Free Kids has gone a long way to destroy the fabric of the tobacco control movement. It is no longer an inclusive, representative, transparent, grassroots movement of dedicated and concerned advocates across the nation. It is now under exclusive control by one organization that has declared itself to be the controlling force for national policy decisions.

So many other national, state, and local tobacco control organizations are extremely unhappy with the way the Campaign has completely co-opted the movement. But they are all afraid to speak out publicly because we are not supposed to criticize other organizations. Plus, the Campaign controls a huge amount of resources in the movement, and no one wants to jeopardize their own funding. Moreover, no one wants to reject this process, revoke their support for the bill, and thus be viewed as the group that killed the legislation.

The rest of the story is that it is now clear that the Campaign for Tobacco-Free Kids, in a move of extreme arrogance, proclaimed itself to be the representative of the entire tobacco control movement in negotiations with Philip Morris that led to the legislation currently before Congress. In the process, the Campaign sold out the public's health to protect the financial interests of the nation's largest tobacco company. The Campaign agreed to unprecedented special protections for Big Tobacco that are enjoyed by no other company whose products are regulated by the Food and Drug Administration.

For those of us in public health, this is an example of obscene policy making. This is politics at its worst. It is the ultimate hypocrisy in tobacco control. It has no place in this movement, and it should be immediately rejected by every tobacco control group that has an interest in the long-term viability of the tobacco control movement.

Friday, May 16, 2008

The Canadian Lung Association apparently will not consider job applications from smokers, no matter how qualified they might be for a position and even if the job is an administrative one and/or has nothing to do with smoking cessation.

A current job opening listed on the Canadian Lung Association web site advertises a position for a web manager. In order to have your application considered, you must be a "qualified non-smoker."

The actual qualifications for the job are as follows:

A Bachelor’s degree in Public Administration, Computer Information Systems, Computer Science, or a closely related field.

Reading knowledge of French.

Experience in developing and running website representing an organization.

Excellent communication skills – written and verbal; follow oral and written instructions.

Strong organizational skills and time management skills to ensure schedules deadlines are met.

Proven ability to work collaboratively and effectively in a team-oriented environment.

Excellent tact and diplomatic skills.

Experience in program and project administration with strong planning, and priority setting.

Analyze problems, identify alternative solutions, project consequences of proposed actions and implement programs in support of program goals.

Maintain confidentiality of client information and records.

The Rest of the Story

The Canadian Lung Association is basically saying that there is no place for smokers in the nation's efforts to improve and promote lung health.

Moreover, the Canadian Lung Association is saying that it is not interested in the most qualified applicants for positions with the Association. Instead, it is interested in seeing applications from potentially less qualified applicants, as long as they do not smoke.

Furthermore, the Canadian Lung Association is engaging in blatant employment discrimination against smokers. Nowhere in the job description for this web manager position is there a job qualification that has anything to do with whether an applicant smokes or not. The Lung Association is acknowledging and documenting for us that being a nonsmoker is not a bona fide job qualification for this position. In fact, it has nothing to do with the position of being a web manager. Thus, accepting applicants from nonsmokers only represents blatant and self-acknowledged employment discrimination.

Among smokers there is undeniably the potential to find the absolutely best qualified applicants for this position. By its willingness to exclude these applicants from consideration, the Canadian Lung Association is sending the message that smokers are not worthy of employment and that they have no role in the fight to promote lung health. This is a tremendous shame, because there is no reason why a smoker could not make a huge contribution to the prevention and treatment of lung diseases.

We in public health should in fact be doing the opposite - encouraging smokers to get involved in the battle to promote the public's health.

There is no justification for the Canadian Lung Association's discrimination against smokers. Through their bigotry, they are not sending a positive message. They are sending a message of fanaticism and intolerance.

Wednesday, May 14, 2008

In response to a New York Timesarticle which uncovered the story about the secret negotiations between the Campaign for Tobacco-Free Kids and Philip Morris that led to the current FDA legislation before Congress, and which revealed the Campaign's sell out in agreeing to exempt menthol from the bill's ban on cigarette flavorings, the Campaign has accused the New York Times of inaccurate reporting and appears to be refuting or at least obscuring the article's primary assertion (which is that the legislation exempts menthol from its ban on cigarette flavorings).

In a communication sent to many of its constituents, the Campaign wrote: "The New York Times today published an article about the pending legislation to grant the FDA authority over tobacco products and how it addresses menthol. The article includes several inaccuracies:

1) The bill does not exempt menthol from FDA regulation."

In the communication, the Campaign also acknowledges that in supporting an exemption for menthol, it was motivated by a desire to keep menthol cigarettes available to millions of addicted smokers: "Currently, menthol cigarettes make up 28 percent of the U.S. cigarette market. As many in the scientific community have pointed out, it is critical to review the science and understand the public health impact before withdrawing from the market a product to which millions are addicted."

The Rest of the Story

The Campaign for Tobacco-Free Kids has itself admitted that the major reason why menthol is not included in the bill's prohibition of cigarette flavorings is that banning menthol would interfere with the sale of such cigarettes to millions of users. The Campaign's expressed concern in agreeing to the menthol exemption, then, is that there are millions of smokers who need menthol cigarettes because they are addicted. The Campaign apparently desires to protect the sale of mentholated tobacco products. In fact, the Campaign is taking precisely the tobacco industry's position on this issue: that we should not remove menthol cigarettes because millions of smokers use this product. In other words, the Campaign itself has essentially admitted that it sold out the public's health in order to protect Big Tobacco profits.

This is one occasion on which the Campaign is absolutely correct. It did sell out the public's health in order to make sure that there is no major interference with the ability of Philip Morris to sell its mentholated cigarette brands. Congress is also happy, of course, because this ensures that there will be no meaningful reduction in cigarette sales, and therefore, no reduction in cigarette tax revenues.

It seems quite apparent to me that the Campaign is not being sincere in its defense of the menthol exemption. As despicable as I find the Campaign's actions in support of this bill, I do not for a minute believe that the Campaign truly believes that it is more important to make sure that menthol cigarettes are available to millions of addicted smokers than to get rid of these products to protect the public's health.

Actually, I think that the Campaign was just backed into a corner, and in its haste to defend its sell-out to Big Tobacco, it stuck its foot in its mouth by making an argument which makes it seem like a true protector of the tobacco industry. No - I don't believe the Campaign is that bad. Instead, I think the Campaign is so determined to hide the truth - that it agreed to this deal because it believed that it needed Philip Morris' support in order to get this legislation enacted - that it is willing to say anything to keep the truth from public health and tobacco control advocates.

Why? Because if the truth is revealed, it will become very difficult for the Campaign to hold together its coalition of groups in support of this legislation. Already, the grassroots membership of many of these organizations are growing impatient. Many local advocates personally oppose the legislation but their hands are tied because the national offices of their organizations support the bill. However, if the truth comes out - that the Campaign negotiated this bill with Philip Morris and that the key provisions in the bill, such as the exemption for menthol, have no public health justification but are present only to appease Philip Morris and protect Big Tobacco profits - then there is a risk that advocates will start to break with their national offices' positions, and the coalition will begin to crumble.

This is, I surmise, why the Campaign felt a need to perform damage control in the wake of the New York Times article. Unfortunately, that damage control has inflicted more damage than they ever could have imagined, because it makes it eminently clear that there is no valid justification for the menthol exemption. It is truly a special protection for Big Tobacco, the precise thing that the Campaign says the legislation is trying to end.

To make matters much worse, the Campaign appears to be attempting to refute and/or obscure the Times' assertion that the bill contains an exemption for menthol in its ban on cigarette flavorings. However, by suggesting that the Times is inaccurate, the Campaign is implying that there is no exemption for menthol in the bill. This is false. The bill does specifically exempt menthol from its ban on cigarette flavorings.

The relevant provision is section 907(a)(1), which states: "A cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or an additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke."

That sounds to me like a pretty clear exemption of menthol from the bill's ban on cigarette flavorings.

In fact, the New York Times was precisely correct in reporting this information, and the Campaign for Tobacco-Free Kids is wrong in refuting the Times' statements and is wrong in accusing the newspaper of inaccurately reporting this information.

It is true that the bill does not completely exempt menthol from FDA regulation, but that is not the point which the article made. By obscuring the issue, the Campaign's statement apparently aims to throw readers off track and take their attention off what is a very clear exemption for menthol from the bill's cigarette flavorings ban. The fact that the FDA could at some point ban menthol in no way can be used to argue that the menthol exemption in section 907(a)(1) does not exist.

It is perfectly appropriate for the Campaign for Tobacco-Free Kids and other anti-smoking groups to support the FDA legislation based on what they see as its merits. However, it is inappropriate for the Campaign to try to hide from its constituents the truth about the legislation: that it does contain an exemption for menthol and that this exemption serves no public health purpose and is present only to protect Big Tobacco financial interests.

Making disingenuous statements to one's constituents is hardly a respectable way of practicing public health. (And if the Campaign is not being disingenuous, and it truly believes that federal tobacco legislation should aim to protect the sale of tobacco products in order not to disrupt the access of millions of smokers to these products, then I think we have worse problems in tobacco control than dishonesty.)

To be honest, I think that right now the tobacco control movement has a lot more important things to worry about than mobilizing to support this flawed FDA legislation. I think first and foremost, it needs to get its house in order. It needs to think about ways to restore some integrity to the public health practice of tobacco control. It needs to think about ways to bring transparency and honesty to the process of national tobacco control policy formation. It needs to devise and act on ways to achieve inclusion of local advocates, and especially advocates of color, in the policy development process.

After all, the FDA legislation is only going to be alive for another couple of months, when it will be vetoed by President Bush. But the tobacco control movement will be alive for years to come, and it needs to be unified, inclusive, honest, ethical, and beyond reproach in its integrity and character for it to remain both alive and effective.

Anti-smoking groups are being blasted, from both the left and the right, for their cave in to Big Tobacco in deciding to exempt menthol from the flavorings that are banned by bills being considered by Congress which would give the Food and Drug Administration (FDA) limited regulatory authority over tobacco products.

An editorial in the Los Angeles Times argues that anti-smoking groups are being dishonest by claiming that the legislation protects our children from death and disease, when those anti-smoking groups are supporting legislation which actually largely exempts African American children from the health protections. It argues, further, that anti-smoking groups are acting in the interest of Philip Morris, not the public's health.

According to the editorial, the legislation bans a host of flavorings, but "stops short of listing the flavoring that actually entices the most smokers: menthol. Mentholated brands, it seems, are simply too important to the industry's bottom line. But let's be clear: It's not the brands that are important, it's the buyers -- African Americans. ... Congress is supposed to be acting in the public's interest, not the tobacco industry's, and one of the alleged goals of the legislation is to reduce smoking's appeal to young people. New smokers often find the taste of tobacco unpleasant or harsh, and tobacco companies have helped ease them into the habit with flavored cigarettes. ... What we're asking for is honesty: The next time the anti-smoking lobby, Philip Morris and certain legislators say this legislation is needed to protect our children, they should have the decency to put the word 'our' in quotations."

Even conservative talk show host Rush Limbaugh has blasted the anti-smoking groups for their hypocrisy. He argues that these groups are not sincere in all their talk about saving lives and protecting children. If they were really sincere, then why the exemption for menthol when all other flavorings are banned?

Rush argues, referring to the menthol exemption: "It still proves that those in government who say they're out to save lives are lying to us. They're not about saving lives. They're about raising taxes. It's about increasing government revenue. It's about keeping people addicted to these things."

The Rest of the Story

Although they represent two extremes on the political spectrum, both the Los Angeles Times and Rush Limbaugh have it exactly right when they argue that anti-smoking groups are being insincere and dishonest in parading about with all their propaganda about saving lives and protecting children through the FDA legislation, when the truth is that in a secret back-room deal, these groups have sold out the health of America's children (especially African-Americans) in order to protect the financial status of Big Tobacco and ensure that cigarettes will continue to be sold at high rates.

You can be on the right, you can be on the left, or you can be anywhere in the middle and it's not hard to see through this charade. Anti-smoking groups (joined by their Congressional "friends") are masquerading around as world saviours, arguing that their interest is in saving "millions" of lives. Yet, the legislation is actually the result of secret negotiations with Philip Morris, in which the anti-smoking groups caved in to protect tobacco interests.

The major reason why menthol is not included in the bill's prohibition of cigarette flavorings is that banning menthol would interfere with the sale of such cigarettes to millions of users. In other words, it is quite true that the Campaign for Tobacco-Free Kids has sold out the public's health in order to make sure that there is no major interference with the ability of Philip Morris to sell its mentholated cigarette brands. Congress is happy, of course, because this ensures that there will be no meaningful reduction in cigarette sales, and therefore, no reduction in cigarette tax revenues.

It is important to note that neither I nor Rush Limbaugh (I never thought we would ever both appear in the same sentence) are arguing that menthol cigarettes should necessarily be prohibited. The argument is more about the hypocrisy and insincerity of the anti-smoking groups then it is about our ideal visions for federal tobacco policy.

What I find unacceptable is not the fact that as a matter of policy, the Campaign for Tobacco-Free Kids and other anti-smoking groups decided not to ban menthol. What is unacceptable is that the Campaign is out there touting this legislation as protecting the public's health, saving our children, saving millions of lives, and ending special protections for Big Tobacco, when the truth is that the bill contains incredible special protections for the industry that are present merely to protect cigarette company profits. And these protections are there because the Campaign for Tobacco-Free Kids negotiated this legislation with Philip Morris.

I don't necessarily have a problem with the idea of crafting legislation to give the FDA regulatory authority over cigarettes. However, if we are going to craft such a bill, it should be done by public health professionals, not by the nation's leading tobacco company. We should not craft the bill by asking Philip Morris what it would like and not like in the legislation. That is simply unacceptable and it is a disservice to the American people.

Tuesday, May 13, 2008

Today, an individual with intimate knowledge of the process that led to the FDA tobacco legislation that is currently before Congress has admitted, for the first time, that the legislation represents the results of a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris and that a major compromise in the bill - the exemption for menthol (all other flavorings were banned) - was inserted to appease Philip Morris and protect its profits.

According to an article in the New York Times: "Some public health experts are questioning why menthol, the most widely used cigarette flavoring and the most popular cigarette choice of African-American smokers, is receiving special protection as Congress tries to regulate tobacco for the first time. ... The reason menthol is seen as politically off limits, despite those concerns, is that mentholated brands are so crucial to the American cigarette industry." ...

"That is why one former public health official says the legislation’s menthol exemption is a “cave-in to the industry,” an opinion shared by some other public health advocates. “I think we can say definitively that menthol induces smoking in the African-American community and subsequently serves as a direct link to African-American death and disease,” said the former official, Robert G. Robinson, who retired two years ago as an associate director in the office of smoking and health at the Centers for Disease Control and Prevention."

"The current lead scientist on tobacco related issues for the C.D.C, Terry F. Pechacek, said the legislation’s exemption for menthol was an issue being discussed in the scientific community. "I would just say this is an area of clear scientific interest and it merits very careful attention." ...

"The legislation is largely a result of negotiations during sessions in 2003 and 2004 between lawmakers, antismoking groups and Philip Morris — the only major American cigarette company that supports the effort to regulate the industry. “My recollection is that we were able to eliminate the use of flavored cigarettes, strawberry, mocha, and all this stuff that is clearly targeted at young kids and to start them smoking tobacco,” Mike DeWine, the former Ohio senator who helped arrange a series of negotiations between Philip Morris and an influential antismoking group, the Campaign for Tobacco-Free Kids, said in a recent telephone interview. “Where the compromise was made as I recall was on menthol,” Mr. DeWine said."

The article confirms what the Rest of the Story has been reporting for several years: that the FDA legislation before Congress is the result of negotiations between anti-tobacco advocates and the leading tobacco company and that the loopholes in the bill are compromises made to appease tobacco industry financial interests.

The Rest of the Story

Shame on the tobacco control groups for selling out the health of African Americans to appease Philip Morris and protect the financial interests of Big Tobacco.

For that reason alone, public health groups should withdraw their support for this legislation, Congress should reject the legislation, and President Bush should veto the bill if it ends up crossing his desk.

Public health practitioners have no business selling out the health of racial/ethnic minority groups in our nation solely to appease Big Tobacco and to protect the profits of the nation's cigarette companies.

Former CDC official and a friend and colleague of mine - Dr. Robert G. Robinson - was right on the mark when he called the FDA tobacco legislation a "cave-in" to the tobacco industry.

What is particularly sad is that the anti-smoking groups will not admit that they caved in to Big Tobacco. Instead, they insist that they are standing up strongly against Big Tobacco. But nothing could be further from the truth, as Dr. Robinson correctly notes.

The rest of the story is that public health and anti-smoking groups caved in to Big Tobacco, and the FDA legislation protects the profits of the nation's largest cigarette company at the expense of the protection of the public's health, especially the protection of the health of African Americans.

If the anti-smoking groups would merely admit that the legislation represents a compromise to appease the interests of Big Tobacco, I might be able to settle for that. But instead, they are hiding the truth from their constituents and the public. This is unethical, because transparency is one of the basic ethical principles of conduct for public health organizations.

Sometimes I wish that I were a leader in a national anti-smoking group, because the job sounds really easy. You get to tell the public that you are fighting Big Tobacco, but when push comes to shove, you actually can take the easy way out. Tell the public that you are getting rid of all flavorings from cigarettes. But when the tough moment comes at the negotiation table, cave in to Philip Morris. Why would you want to actually set a policy that would do something substantial to protect the public's health? It's much easier to get rid of the chocolate and strawberry - flavorings that aren't even being used. You can be all talk, and no walk. You can be all fluff, and no substance.

Things are different here in the tobacco control trenches. We (grassroots advocates) are the ones who really put up the fight. We do things the hard way. We don't take the politically expedient path. And that's why what we do actually makes a difference.

One final note. It is disturbing to me that the CDC spokesperson was unwilling to take a position. Clearly, he was trying to walk a tightrope and stay on the fence, so as not to alienate the nation's major anti-smoking groups. But his responsibility I believe as a public health practitioner was to tell the truth: that from a public health perspective, menthol should be eliminated if we are going to eliminate all other flavorings. There is no public health justification for the exemption of menthol. His unwillingness to take a stand is disappointing.

At the end of the day, it is sad to me that the Campaign for Tobacco-Free Kids, American Medical Association, and other major national anti-smoking groups have caved in to Big Tobacco, selling out the health of African Americans in order to protect cigarette company profits.

I guess poetic justice will be served when George W. is the one to send them the wake-up call. With his veto, he will ironically be the one who is standing up to protect the public's health. It may be the only time in his presidency, but it will be sweet, and the African American community deserves nothing less.

Monday, May 12, 2008

A press release issued by the Agency for Healthcare Research & Quality (AHRQ) to publicize the findings of a review by an expert panel of the role of clinicians in smoking cessation fails to disclose the significant financial conflicts of interests of the panelists.

The press release explains that: "The review found that there are now seven medications approved by the Food and Drug Administration as smoking cessation treatments that dramatically increase the success of quitting. The medications are: bupropion SR, nicotine gum, nicotine inhaler, nicotine lozenge, nicotine nasal spray, nicotine patch, and varenicline."

The press release fails to also mention that other research indicates that the overwhelming majority of smokers who quit successfully for the long-term do so via a cold turkey, and not a medication-based approach.

Nowhere, however, does the press release mention that 9 of the members of the expert panel, including its chair, have financial conflicts of interest by virtue of having received money from Big Pharma. Most of the companies from which funding was received are precisely those which manufacture or distribute smoking cessation medications, and which therefore stand to gain financially from the panel's recommendations.

A search of the other online materials regarding the Clinical Practice Guideline (not including the guideline itself) revealed that outside of the guideline itself, the financial conflicts of interest are not disclosed.

The Rest of the Story

I view it as being unethical for the Agency to report the results of the panel's recommendations without disclosing the fact that many of the expert panelists, including its chair, had financial conflicts of interest, namely, a history of funding by pharmaceutical companies that stand to gain from the recommendations contained in the report.

While allowing conflicted individuals to serve on the panel is itself questionable, the failure to disclose the conflict in reports of the findings of the panelists is indefensible.

In many cases, financial conflicts of interest are present but do not appear to have interfered with the objectivity of the research. In this case, it is quite clear to me that the conflicts did interfere with the integrity of this work. The panel largely ignored the population-based data demonstrating that the majority of smokers who quit long-term do so cold turkey, without the aid of pharmaceuticals. The panel also largely over-estimated the benefits of pharmaceutical aids, relying heavily upon clinical trials in which patients were not truly blinded to their treatment status. In addition, the panel relied too heavily upon studies conducted in a clinical setting and ignored studies conducted in real-life, population-based settings.

This is a great example of what can happen when we allow science to be prostituted by the potential for personal financial gain. One could argue that money always interferes in some way with the objectivity of scientific research; however, it usually doesn't interfere to this degree and there is no excuse for allowing conflicts of this magnitude to occur. It is even less excusable to fail to report such conflicts.

Thursday, May 08, 2008

An NIH expert panel this week released a 2008 update of the clinical practice guideline regarding the treatment of tobacco use and dependence (see: Fiore MC, Jaén CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008).

The guideline recommends that every patient who wishes to quit be treated with pharmaceuticals, unless medically contraindicated. The guideline also recommends the use of Chantix, despite concerns about its potential suicide risk, a risk that is currently being investigated by the FDA. Among the pharmaceuticals recommended by the panel are:

buproprion;

nicotine gum;

nicotine patch;

nicotine nasal spray;

nicotine lozenge;

nicotine inhaler;

Chantix; and

combinations of the above.

The Rest of the Story

Far from being an objective review and assessment of the best possible strategy to enhance smoking cessation among smokers in the United States, the guideline is a heavily biased analysis that is plagued by the presence of severe financial conflicts of interests among the panel's chair and at least 8 of its other members.

These 9 panel members have received, or are currently receiving, funding from pharmaceutical companies. Most of the involved companies stand to gain from the clinical practice guideline's recommendations, because these companies manufacture drugs recommended by the panel.

Here is the long list of financial conflicts of interest among this supposedly objective panel of expert scientists:

Michael C. Fiore: "reported that he served as an investigator on research studies at the University of Wisconsin (UW) that were supported wholly or in part by four pharmaceutical companies, and in 2005 received compensation from one pharmaceutical company. In addition, he reported that, in 1998, the UW appointed him to a named Chair, which was made possible by an unrestricted gift to the UW from GlaxoWellcome."

William C. Bailey: "reported significant financial interests in the form of compensation from three different pharmaceutical companies in 2006 and two in 2007 for speaking engagements."

Timothy B. Baker: "reported that he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

Neal L. Benowitz: "reported significant financial interest in the form of compensation from one pharmaceutical company for each of the years 2005-2007, as well as stock ownership in one pharmaceutical company."

Michael G. Goldstein: "reported that his employer received support from Bayer Pharmaceutical prior to 2005 and that he was employed by Bayer Pharmaceutical Corporation prior to January 1, 2005. His organization received payments for his professional services from two pharmaceutical companies and one commercial Internet smoking cessation site during the period 2005-2007."

Harry A. Lando: "reported serving on an advisory panel for a new tobacco use cessation medication and attending 2-day meetings in 2005 and 2006 as a member of this panel."

C. Tracy Orleans: "reported significant financial interests in the form of a dependent child who owns pharmaceutical stock... ."

Maxine L. Stitzer: "reported participation on a pharmaceutical scientific advisory panel for a new tobacco use cessation medication."

Sally Faith Dorfman: "reported her employment by Ferring Pharmaceuticals, Inc., a company whose business does not relate to treating tobacco dependence."

GlaxoWellcome, which apparently endowed the Chair position that the chair of the panel enjoys, is the manufacturer of Wellbutrin, Commit lozenge, Committed Quitters, NiQuitin/Nicoderm, Nicabate, and Nicorette. The use of all of these drugs is recommended by the panel.

What this means is that we basically have a group of experts who are largely financially linked with pharmaceutical companies, and who stand to gain personally if they recommend the use of pharmaceuticals as part of their smoking cessation guidelines. The more use of pharmaceuticals they recommend, the more they stand to gain.

This is a conflict of interest in the ugliest way that I can imagine. It is precisely the type of thing that needs to be stopped.

Ironically, it is the Department of Health and Human Services, the Public Health Service, and NIH itself which are regulating conflicts of interest among America's medical researchers. To have such a huge conflict of interest in its own supported work is unconscionable.

While I find it objectionable that these agencies would allow experts with these type of financial conflicts of interest to serve on the panel, I find it equally troubling that such individuals would agree to serve. I believe that based on these conflicts, these experts should have recused themselves from service on the panel.

The conflict in this case is not just a hypothetical one. It reveals itself in the extreme bias of the guideline. The analysis over-estimates the benefit of drugs in smoking cessation and overlooks population-based evidence showing that most people who quit smoking do so without pharmaceutical aids.

As my colleague Dr. Lois Biener of the University of Massachusetts Boston argued in an Associated Press article about the guideline, there is little if any "real-world evidence" that when used outside the context of clinical trials, drugs produce any long-term enhancement of smoking cessation, and certainly not the magnitude of benefit as suggested by those who are touting the importance of these drugs.

According to the article: "Lois Biener, a researcher of tobacco use and control efforts at the University of Massachusetts in Boston, said most people who quit do so without smoking-cessation drugs. There's little evidence that these drugs are superior in the long run to quitting without help, and while a few studies have shown some benefit, it's 'way less than what is claimed' by medication advocates, Biener said."

One national expert on smoking cessation who was not on the panel - John Polito - suggested in the article that the guideline is basically a "sales pitch" for the pharmaceutical industry, that the benefits of pharmaceuticals are overstated, that the value of quitting cold turkey is not considered, and that the recommendation to promote Chantix use is misguided and could cause harm.

According to the article: "Fiore's views are shaped by his past ties to the drug industry, and those ties still pose a conflict, at least one consumer advocate said. John Polito, a smoking cessation educator who runs the WhyQuit.com site advocating quitting 'cold turkey,' called the revised guidelines 'a sales pitch' for the drug industry. The task force overlooked research showing that quitting cold turkey works, Polito said, and studies showing Chantix is superior don't reflect how it's used 'in the real world.' 'People are quitting smoking to save their lives,' Polito said. If Chantix's risks outweigh its benefits, 'then it's insane for people to risk their lives' by using it, he said."

Polito has really stated it better than I could and he is right on the mark. The guideline is basically a sales pitch for the pharmaceutical industry, and it demonstrates what corporations can buy through their payments to scientific experts.

What's most disturbing to me is that while the medical field continues to move to decrease the influence of pharmaceutical companies on physicians by restricting financial benefits for doctors, the tobacco control field seems to be increasingly plagued by this pharmaceutical influence. The problem is being ameliorated in medicine, but in tobacco control, it continues to get worse.

The ultimate irony of all of this is that we in tobacco control have been so vehement in decrying the tobacco industry's influence on science. We have attacked and berated scientists for having financial ties to tobacco companies. We have discredited scientific conclusions based solely on the financial connections of the authors to Big Tobacco. But now, our national policies are being set by individuals who have equally strong connections to Big Pharma.

It may come as a surprise to many in tobacco control, but this type of science is just as bad. Bad science is bad science. Conflicts of interest are conflicts of interest. Believe me, the science doesn't get any stronger just because it is a less detestable industry. As a field which has literally helped to ruin the careers of scientists with tobacco industry connections, we should be beyond reproach in not allowing similar conflicts of interest to degrade and poison our science.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.